CN109106743B - Blood circulation promoting and pain relieving capsule and preparation method thereof - Google Patents
Blood circulation promoting and pain relieving capsule and preparation method thereof Download PDFInfo
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- CN109106743B CN109106743B CN201811134776.7A CN201811134776A CN109106743B CN 109106743 B CN109106743 B CN 109106743B CN 201811134776 A CN201811134776 A CN 201811134776A CN 109106743 B CN109106743 B CN 109106743B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/232—Angelica
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/24—Heavy metals; Compounds thereof
- A61K33/26—Iron; Compounds thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/63—Arthropods
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/63—Arthropods
- A61K35/64—Insects, e.g. bees, wasps or fleas
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/258—Panax (ginseng)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/32—Burseraceae (Frankincense family)
- A61K36/324—Boswellia, e.g. frankincense
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/04—Drugs for skeletal disorders for non-specific disorders of the connective tissue
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
Abstract
The invention belongs to the technical field of medicines, and particularly relates to a blood circulation promoting and pain relieving capsule and a preparation method thereof. The invention relates to a blood-activating pain-relieving capsule, which consists of blood-activating pain-relieving mixed powder and a capsule shell, wherein the blood-activating pain-relieving mixed powder comprises the following components in parts by weight: 190 parts of angelica sinensis sterilization powder 170, 30-40 parts of pseudo-ginseng sterilization powder, 30-40 parts of vinegar frankincense, 50-60 parts of calcined native copper sterilization powder, 80-100 parts of ground beetle sterilization powder and 8-10 parts of borneol. The capsule for promoting blood circulation and relieving pain provided by the invention has the advantages of low hygroscopicity, good stability, high bioavailability and easy disintegration, and the mixed powder has low hygroscopicity and high fluidity in the preparation process, so that the prepared capsule for promoting blood circulation and relieving pain has uniform quality, the problem of quality difference in capsule filling is solved, the disintegration of the medicine is promoted, the stability of the medicine is enhanced, and the product quality is high.
Description
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to a blood circulation promoting and pain relieving capsule and a preparation method thereof.
Background
Blood stasis stagnation of skin during acute soft tissue injury can cause local pain and swelling, and blood stasis can cause unsmooth blood flow and microcirculation disturbance, and exudation, swelling and other manifestations. The blood-activating and pain-relieving capsule has the effects of relieving swelling and pain, and promoting blood circulation to remove blood stasis, and is clinically used for treating diseases such as swelling and pain, blood stasis, traumatic injury, arthralgia, rheumatism and the like. For treating traumatic injury, western medicines mainly take non-steroidal anti-inflammatory analgesics as main materials, and compared with the blood circulation promoting and pain relieving capsules, the blood circulation promoting and pain relieving capsules have the effects of relieving pain and dissipating blood stasis. Compared with the similar Chinese patent medicines, the Chinese patent medicine has the advantages of cheap and easily obtained raw materials.
Chinese patent application CN106880656A discloses a blood-activating pain-relieving capsule, which is prepared from the following raw materials in parts by mass: 40-50 parts of angelica, 8-10 parts of pseudo-ginseng, 8-10 parts of prepared frankincense, 2-3 parts of borneol, 20-24 parts of ground beeltle, 10-12 parts of forged native copper, 0.2-2 parts of auxiliary materials and 0.001-0.002 part of preservative. Although the capsule for promoting blood circulation and relieving pain has good curative effect and less side effect, the auxiliary materials and the preservative are added, so that the quality stability of the medicine is improved. However, since the dry paste is obtained by mixing the dry paste with an auxiliary material, the fluidity and uniformity of the capsule contents are poor, there is a problem of quality variation during capsule filling, and the long-term stability is not satisfactory.
In the prior art for preparing the capsule for activating blood circulation and relieving pain, the auxiliary materials are superfine silica gel powder and starch which have strong hygroscopicity, and the phenomena of high moisture content, difficulty in disintegration of capsule contents and the like are frequently generated in the storage process. In addition, the existing blood-activating pain-relieving capsules are not ideal in long-term stability.
Disclosure of Invention
Aiming at the defects of the prior art, the invention aims to provide a blood-activating pain-relieving capsule and a preparation method thereof. The blood circulation promoting and pain relieving capsule provided by the invention has the advantages of low hygroscopicity, good stability, high bioavailability and easiness in disintegration, and the mixed powder in the preparation process has low hygroscopicity and high fluidity, so that the prepared blood circulation promoting and pain relieving mixed powder has uniform quality, the problem of quality difference in capsule filling is solved, the medicine disintegration is promoted, the medicine stability is enhanced, the long-term stability of the product is excellent, and the product quality is high.
The technical scheme of the invention is as follows:
the blood circulation promoting and pain relieving capsule consists of blood circulation promoting and pain relieving mixed powder and a capsule shell, wherein the blood circulation promoting and pain relieving mixed powder comprises the following components in parts by weight:
190 parts of angelica sinensis sterilization powder 170, 30-40 parts of pseudo-ginseng sterilization powder, 30-40 parts of vinegar frankincense, 50-60 parts of calcined native copper sterilization powder, 80-100 parts of ground beetle sterilization powder and 8-10 parts of borneol.
Further, the blood circulation promoting and pain relieving capsule consists of blood circulation promoting and pain relieving mixed powder and a capsule shell, wherein the blood circulation promoting and pain relieving mixed powder comprises the following components in parts by weight:
179.82 parts of angelica sinensis sterilization powder, 35.64 parts of pseudo-ginseng sterilization powder, 35.64 parts of vinegar frankincense, 54.27 parts of calcined native copper sterilization powder, 89.91 parts of ground beetle sterilization powder and 8.91 parts of borneol.
Further, the blood circulation promoting and pain relieving mixed powder also comprises 8-16 parts of pharmaceutically acceptable auxiliary materials.
Furthermore, the mixed powder for promoting blood circulation and relieving pain also comprises 12 parts of pharmaceutically acceptable auxiliary materials.
Further, the pharmaceutically acceptable auxiliary materials comprise modified starch, magnesium stearate, polyvinylpyrrolidone and pectin according to a mass ratio of 18-22:7-10:4-6: 1-3.
Furthermore, the pharmaceutically acceptable auxiliary materials comprise modified starch, magnesium stearate, polyvinylpyrrolidone and pectin according to a mass ratio of 20:9:5: 2.
Further, the preparation method of the modified starch comprises the following steps:
(1) taking starch and hydroxyethyl cellulose, wherein the mass ratio of the starch to the hydroxyethyl cellulose is 6:1, adding water, wherein the addition amount of the water is 9 times of the mass of the starch, stirring to obtain an emulsion, and adjusting the pH of the emulsion to 8.0 by using a sodium hydroxide aqueous solution with the mass concentration of 2% to obtain a mixed solution;
(2) taking octenyl succinic anhydride, wherein the mass of the octenyl succinic anhydride is 2% of that of the starch in the step (1), and adding absolute ethyl alcohol, wherein the addition amount of the absolute ethyl alcohol is 5 times of that of the octenyl succinic anhydride, so as to obtain an alcohol solution;
(3) adding the alcohol solution obtained in the step (2) into the mixed solution obtained in the step (1), stirring and reacting for 6 hours at 40 ℃, adjusting the pH of the system to 6.5 by using a hydrochloric acid solution with the concentration of 1mol/L after the reaction is finished, and performing suction filtration, drying and crushing to obtain an intermediate product;
(4) adding water into the intermediate product obtained in the step (3), wherein the addition amount of the water is 2 times of the mass of the intermediate product, uniformly stirring, adding anhydrous sodium sulfate, the addition amount of the anhydrous sodium sulfate is 1/5 of the mass of the intermediate product, uniformly stirring, adjusting the pH of the system to 11.5 by using a sodium hydroxide solution with the concentration of 1mol/L, stirring for 30min at room temperature, adding propylene oxide, the addition amount of the propylene oxide is 1/5 of the mass of the intermediate product, stirring for 30min at room temperature, reacting for 10h at 40 ℃, adjusting the pH of the system to 6.5 by using a hydrochloric acid solution with the concentration of 1mol/L after the reaction is finished, and performing suction filtration, drying and crushing to obtain the intermediate product.
In addition, the invention also provides a preparation method of the blood circulation promoting and pain relieving capsule, which comprises the following steps:
s1, weighing borneol respectively, and manually and uniformly mixing the borneol and the angelica sinensis sterilization powder with the same mass as the borneol to obtain mixed powder I; weighing angelica sterilizing powder 2 times the mass of borneol and the mixed powder I, adding the mixture into a two-dimensional motion mixer, starting up the two-dimensional motion mixer, mixing for 3 minutes, stopping the two-dimensional motion mixer, opening a total mixing tank, adding the angelica sterilizing powder 4 times the mass of the borneol, starting up the two-dimensional motion mixer, mixing for 3 minutes, and stopping the two-dimensional motion mixer; opening the total mixing tank, adding the rest of the angelica sinensis sterilization powder, starting the machine for mixing for 5 minutes, and discharging to obtain a material; pulverizing the above materials with GFSJ-16 high efficiency pulverizer, sieving with 14 mesh sieve to obtain GUIBINGBING powder;
s2, respectively weighing vinegar frankincense and calcined native copper sterilizing powder, smashing the weighed vinegar frankincense into small blocks of 2cm by using a stainless steel hammer to obtain vinegar frankincense blocks, uniformly mixing the vinegar frankincense blocks and the calcined native copper sterilizing powder according to the ratio of 2:3, crushing by using a GFSJ-16 efficient crusher, sieving by using a 14-mesh inspection sieve after crushing, and sieving to obtain vinegar frankincense and calcined native copper mixed powder;
s3, sequentially putting the angelica and borneol mixed powder obtained in the step S1, the ground beeltle sterilization powder, the vinegar frankincense and calcined pyrite mixed powder obtained in the step S2 and the pseudo-ginseng sterilization powder into a EYH-1000 type two-dimensional motion mixer for total mixing for 30 minutes at the rotating speed frequency of 35-40 Hz to obtain the blood circulation-activating and pain-relieving mixed powder;
s4, filling the mixed powder for promoting blood circulation and relieving pain obtained in the step S3 with a capsule shell, wherein the marked filling amount is 0.25 g/capsule, and the Chinese medicine preparation is obtained.
Further, in step S3, pharmaceutically acceptable excipients are also added.
Further, in the step S4, the capsule shell is a No. 1 all-red empty capsule.
In the invention, the raw materials are as follows:
chinese angelica: a primitive: is dried root of Angelica sinensis (Oliv.) Diels) belonging to family Umbelliferae. Medicine property: sweet, pungent and warm. It enters liver, heart and spleen meridians. The functions and indications are as follows: tonify blood, activate blood, regulate menstruation, alleviate pain, moisten intestines to relieve constipation. Can be used for treating blood deficiency, sallow complexion, giddiness, palpitation, menoxenia, amenorrhea, dysmenorrhea, asthenia cold, abdominal pain, constipation due to intestinal dryness, rheumatic arthralgia, traumatic injury, superficial infection, pyocutaneous disease. Purifying the angelica: removing impurities and moldy, deteriorated and dry oil-free waste products, cleaning with flowing drinking water, moistening, draining, and cutting into pieces with thickness of less than or equal to 5mm with a medicine cutting machine. Drying in CT-C-II hot air circulation oven or KWZG-30 microwave vacuum drier until water content is less than 5%, drying, micronizing with WFJ-15 type micronizer until 100% of the fine powder is sieved with 80 mesh sieve and 95% of the fine powder is sieved with 100 mesh sieve to obtain pulverized radix Angelicae sinensis powder. Chinese angelica sterilizing powder: transferring the pulverized radix Angelicae sinensis powder to a sterilization room, sterilizing with CT-C-II type hot air circulation oven, controlling the thickness of tray material to be less than or equal to 3mm, sterilizing at 103 + -3 deg.C for 2 hr.
Pseudo-ginseng: a primitive: is dried root of Panax notoginseng (Burk.) F.H.Chen of Araliaceae. Medicine property: sweet, slightly bitter and warm. It enters liver and stomach meridians. The functions and indications are as follows: disperse blood stasis, stop bleeding, resolve swelling and alleviate pain. Can be used for treating hemoptysis, hematemesis, epistaxis, hematochezia, metrorrhagia, traumatic hemorrhage, thoracico-abdominal pain, and traumatic swelling and pain. And (3) cleaning the pseudo-ginseng: selecting impurities and moldy and deteriorated waste products, cleaning with flowing drinking water, draining, coarsely crushing with a powerful coarse crusher, drying in a CT-C-II type hot air circulation oven or a KWZG-30 type microwave vacuum dryer, drying until the water content of the dried medicinal material is less than or equal to 5%, crushing with a WFJ-15 type micro crusher after drying, wherein 100% of the crushed fine powder is required to pass through an 80-mesh sieve, and more than 95% of the crushed fine powder can pass through a 100-mesh sieve, thus obtaining the well-crushed pseudo-ginseng powder. Notoginseng sterilizing powder: transferring pulverized Notoginseng radix powder to sterilization room, sterilizing with CT-C-II type hot air circulation oven, controlling the thickness of tray material to be less than or equal to 3mm, sterilizing at 103 + -3 deg.C for 2 hr.
Frankincense: a primitive: resin exuded from the bark of Boswellia carterii Birdw of the family Burseraceae and Boswellia bhaw-dajiana Birdw of the same genus. Medicine property: pungent, bitter and warm. It enters heart, liver and spleen meridians. The functions and indications are as follows: promoting blood circulation, relieving pain, eliminating swelling, and promoting granulation. Can be used for treating thoracic obstruction, cardialgia, epigastralgia, dysmenorrhea, amenorrhea, puerperal blood stasis, abdominal mass, rheumatalgia, spasm of muscles and tendons, traumatic injury, carbuncle, swelling, and pyocutaneous disease. The vinegar processed Olibanum is processed product of Olibanum. The preparation method of the vinegar mastic comprises the following steps: removing impurities from Olibanum, adding vinegar (5 kg per 100kg Olibanum), stirring, stewing thoroughly (24 hr), parching in pan to black and bright, taking out, cooling, and crushing into small pieces.
Calcining Pyritum: is pyrite of pyrite family, which is sulfide mineral and mainly contains iron disulfide (FeS)2) And (3) medicinal property: pungent and mild with the action of promoting reunion of fractured tendons and bones. Calcining Pyritum: calcining clean Pyritum to dark red by calcining method (appendix II D), and quenching with vinegar until the surface turns black brown, and the luster disappears and is loose. And (4) crushing the calcined pyrite by using a WFJ-15 type micro crusher to obtain the well-crushed calcined pyrite powder. Calcining Pyritum sterilizing powder: transferring the crushed calcined natural copper powder to a sterilization room, and sterilizing by using a CT-C-II type hot air circulation oven, wherein the thickness of the tray material is less than or equal to 3mm, the sterilization temperature is controlled at 103 +/-3 ℃, and the sterilization time is 2 hours.
Ground beetle: a primitive: is the dried female insect of Eupolyphaga sinensis Walker or Plenophaga plancyi (Boleny) of Eupolyphaga of Corydaceae. Medicine property: salty and cold; has little toxicity. It enters liver meridian. The functions and indications are as follows: break blood and remove stasis, reunion of fractured tendons and bones. Cleaning ground beetles: removing impurities and moldy and deteriorated waste, cleaning with flowing drinking water, moistening thoroughly, and draining. Drying in CT-C-II type hot air circulation oven or KWZG-30 type microwave vacuum drier until water content is less than or equal to 5%, and pulverizing with WFJ-15 type micro pulverizer to obtain pulverized Eupolyphaga Seu Steleophaga powder. Ground beetle sterilization powder: transferring the ground Eupolyphaga Seu Steleophaga powder to a sterilization room, sterilizing with CT-C-II type hot air circulation oven, wherein the thickness of tray material is less than or equal to 3mm, the sterilization temperature is controlled at 123 + -3 deg.C, and the sterilization time is 3 hr.
Borneol: a primitive: is natural crystalline compound separated from resin of Borneolum perfume plant, such as Borneolum tree. Medicine property: pungent, bitter and slightly cold. It enters heart, spleen and lung meridians. The functions and indications are as follows: induce resuscitation and refresh mind, clear heat and alleviate pain.
The invention has reasonable prescription and refined compatibility, wherein the angelica is a monarch drug and is used for enriching blood, promoting blood circulation, removing blood stasis and promoting blood generation. The ground beetle is a ministerial drug, and has the effects of breaking hard mass, removing blood stasis, healing wound and relieving pain. The formula mainly promotes blood circulation and promotes absorption of blood stasis, and has a synergistic effect with the monarch drug angelica to enhance the analgesic effect. Sanqi tonifies blood, dispels stasis and relieves pain. Frankincense with olibanum has the effects of promoting qi and blood circulation, and eliminating swelling and promoting granulation. The native copper is used for dissipating blood stasis, setting broken bone and relieving pain, can assist the main drug angelica to promote the dissipation of blood stasis purpura, and can promote the healing of fracture and the repair of tissues together with the frankincense. Borneol can clear heat, induce resuscitation, relieve swelling and alleviate pain. The components of the invention are mutually cooperated to play the effects of promoting blood circulation, removing blood stasis, reducing swelling and relieving pain.
In the prior art for preparing the capsule for activating blood circulation and relieving pain, the auxiliary materials are superfine silica gel powder and starch which have strong hygroscopicity, and the phenomena of high moisture content, difficulty in disintegration of capsule contents and the like are frequently generated in the storage process. The invention is a pharmaceutically acceptable auxiliary material composed of modified starch, magnesium stearate, polyvinylpyrrolidone and pectin according to a certain mass ratio, which can effectively improve the hygroscopicity, the fluidity and the uniformity of mixed powder, so that the prepared blood-activating pain-relieving capsule has uniform quality, solves the problem of quality difference in capsule filling, promotes the disintegration of the medicine, improves the dissolution rate of the medicine, enhances the stability of the medicine and improves the product quality.
According to the invention, the starch is modified, so that the hygroscopicity of the blood-activating and pain-relieving mixed powder is reduced, the fluidity of the blood-activating and pain-relieving mixed powder is increased, the quality of the prepared blood-activating and pain-relieving mixed powder is uniform, the problem of quality difference in capsule filling is solved, and the medicine absorption can be promoted; in addition, the pectin is added, so that the gastrointestinal mucosa can be protected, the long-term stability of the medicine can be improved, and the quality guarantee period of the capsule can be prolonged; in addition, the pectin can also act synergistically with the modified starch, so that the irritation of the medicine to the gastrointestinal tract is avoided, and the bioavailability is improved, thereby further reducing the dosage and adverse reactions.
Compared with the prior art, the invention has the following advantages:
(1) the blood-activating and pain-relieving capsule provided by the invention has the effects of activating blood and removing stasis, and relieving swelling and pain. Can be used for treating traumatic injury, and swelling and pain due to blood stasis. Has remarkable curative effect on sports injury, lumbar muscle strain, ligament injury, knee joint meniscus injury and the like.
(2) The blood-activating pain-relieving capsule of the invention not only can relieve pain, but also has the efficacy of dissipating blood stasis, and compared with the similar Chinese patent medicines, has the advantages of cheap and easily obtained raw materials.
(3) The capsule for promoting blood circulation and relieving pain provided by the invention has the advantages of low hygroscopicity, good stability, high bioavailability and easy disintegration, and the mixed powder in the preparation process has low hygroscopicity and high fluidity, so that the prepared capsule for promoting blood circulation and relieving pain has uniform quality, the problem of quality difference in capsule filling is solved, the disintegration of the medicine is promoted, the stability of the medicine is enhanced, and the product quality is high.
Detailed Description
The present invention is further described in the following description of the specific embodiments, which is not intended to limit the invention, but various modifications and improvements can be made by those skilled in the art according to the basic idea of the invention, within the scope of the invention, as long as they do not depart from the basic idea of the invention.
In the invention, the polyvinylpyrrolidone can be purchased from Wuhan La Na white pharmaceutical chemical Co Ltd, pharmaceutical grade; hydroxyethyl cellulose is available from ten thousand new materials, ltd, guangzhou, cat #: r-1716; starch is available from West Anyuelay pharmaceutical science and technology, Inc., pharmaceutical grade.
Example 1A blood circulation promoting and pain relieving Capsule
The blood circulation promoting and pain relieving capsule consists of blood circulation promoting and pain relieving mixed powder and a capsule shell, wherein the blood circulation promoting and pain relieving mixed powder consists of the following components in parts by weight:
170 parts of angelica sinensis sterilization powder, 30 parts of pseudo-ginseng sterilization powder, 30 parts of vinegar frankincense, 50 parts of calcined native copper sterilization powder, 80 parts of ground beeltle sterilization powder and 8 parts of borneol.
The preparation method of the capsule for promoting blood circulation and relieving pain comprises the following steps:
s1, weighing borneol respectively, and manually and uniformly mixing the borneol and the angelica sinensis sterilization powder with the same mass as the borneol to obtain mixed powder I; weighing angelica sterilizing powder 2 times the mass of borneol and the mixed powder I, adding the mixture into a two-dimensional motion mixer, starting up the two-dimensional motion mixer, mixing for 3 minutes, stopping the two-dimensional motion mixer, opening a total mixing tank, adding the angelica sterilizing powder 4 times the mass of the borneol, starting up the two-dimensional motion mixer, mixing for 3 minutes, and stopping the two-dimensional motion mixer; opening the total mixing tank, adding the rest of the angelica sinensis sterilization powder, starting the machine for mixing for 5 minutes, and discharging to obtain a material; pulverizing the above materials with GFSJ-16 high efficiency pulverizer, sieving with 14 mesh sieve to obtain GUIBINGBING powder;
s2, respectively weighing vinegar frankincense and calcined native copper sterilizing powder, smashing the weighed vinegar frankincense into small blocks of 2cm by using a stainless steel hammer to obtain vinegar frankincense blocks, uniformly mixing the vinegar frankincense blocks and the calcined native copper sterilizing powder according to the ratio of 2:3, crushing by using a GFSJ-16 efficient crusher, sieving by using a 14-mesh inspection sieve after crushing, and sieving to obtain vinegar frankincense and calcined native copper mixed powder;
s3, sequentially putting the angelica and borneol mixed powder obtained in the step S1, the ground beeltle sterilization powder, the vinegar frankincense and calcined pyrite mixed powder obtained in the step S2 and the pseudo-ginseng sterilization powder into a EYH-1000 type two-dimensional motion mixer for total mixing, wherein the mixing time is 30 minutes, and the rotating speed frequency of the mixer is 35Hz, so that the blood circulation activating and pain relieving mixed powder is obtained;
s4, filling the blood circulation-promoting and pain-relieving mixed powder obtained in the step S3 into a No. 1 all-red empty capsule, wherein the marked filling amount is 0.25 g/capsule, and the Chinese medicine composition is obtained.
Example 2A blood circulation promoting and pain relieving Capsule
The blood circulation promoting and pain relieving capsule consists of blood circulation promoting and pain relieving mixed powder and a capsule shell, wherein the blood circulation promoting and pain relieving mixed powder consists of the following components in parts by weight:
190 parts of angelica sinensis sterilization powder, 40 parts of pseudo-ginseng sterilization powder, 40 parts of vinegar frankincense, 60 parts of calcined pyrite sterilization powder, 100 parts of ground beeltle sterilization powder and 10 parts of borneol.
The preparation method of the capsule for promoting blood circulation and relieving pain comprises the following steps:
s1, weighing borneol respectively, and manually and uniformly mixing the borneol and the angelica sinensis sterilization powder with the same mass as the borneol to obtain mixed powder I; weighing angelica sterilizing powder 2 times the mass of borneol and the mixed powder I, adding the mixture into a two-dimensional motion mixer, starting up the two-dimensional motion mixer, mixing for 3 minutes, stopping the two-dimensional motion mixer, opening a total mixing tank, adding the angelica sterilizing powder 4 times the mass of the borneol, starting up the two-dimensional motion mixer, mixing for 3 minutes, and stopping the two-dimensional motion mixer; opening the total mixing tank, adding the rest of the angelica sinensis sterilization powder, starting the machine for mixing for 5 minutes, and discharging to obtain a material; pulverizing the above materials with GFSJ-16 high efficiency pulverizer, sieving with 14 mesh sieve to obtain GUIBINGBING powder;
s2, respectively weighing vinegar frankincense and calcined native copper sterilizing powder, smashing the weighed vinegar frankincense into small blocks of 2cm by using a stainless steel hammer to obtain vinegar frankincense blocks, uniformly mixing the vinegar frankincense blocks and the calcined native copper sterilizing powder according to the ratio of 2:3, crushing by using a GFSJ-16 efficient crusher, sieving by using a 14-mesh inspection sieve after crushing, and sieving to obtain vinegar frankincense and calcined native copper mixed powder;
s3, sequentially putting the angelica and borneol mixed powder obtained in the step S1, the ground beeltle sterilization powder, the vinegar frankincense and calcined pyrite mixed powder obtained in the step S2 and the pseudo-ginseng sterilization powder into a EYH-1000 type two-dimensional motion mixer for total mixing, wherein the mixing time is 30 minutes, and the rotating speed frequency of the mixer is 40Hz, so that the blood circulation activating and pain relieving mixed powder is obtained;
s4, filling the blood circulation-promoting and pain-relieving mixed powder obtained in the step S3 into a No. 1 all-red empty capsule, wherein the marked filling amount is 0.25 g/capsule, and the Chinese medicine composition is obtained.
Example 3A blood circulation promoting and pain relieving Capsule
The blood circulation promoting and pain relieving capsule consists of blood circulation promoting and pain relieving mixed powder and a capsule shell, wherein the blood circulation promoting and pain relieving mixed powder consists of the following components in parts by weight:
179.82 parts of angelica sinensis sterilization powder, 35.64 parts of pseudo-ginseng sterilization powder, 35.64 parts of vinegar frankincense, 54.27 parts of calcined native copper sterilization powder, 89.91 parts of ground beetle sterilization powder and 8.91 parts of borneol.
The preparation method of the blood circulation promoting and pain relieving capsule is similar to that of example 1.
Example 4A blood circulation promoting and pain relieving Capsule
The blood circulation promoting and pain relieving capsule consists of blood circulation promoting and pain relieving mixed powder and a capsule shell, wherein the blood circulation promoting and pain relieving mixed powder consists of the following components in parts by weight:
179.82 parts of angelica sinensis sterilization powder, 35.64 parts of pseudo-ginseng sterilization powder, 35.64 parts of vinegar frankincense, 54.27 parts of calcined native copper sterilization powder, 89.91 parts of ground beetle sterilization powder, 8.91 parts of borneol and 12 parts of pharmaceutically acceptable auxiliary materials; the pharmaceutically acceptable auxiliary materials comprise modified starch, magnesium stearate, polyvinylpyrrolidone and pectin according to a mass ratio of 20:9:5: 2.
The preparation method of the modified starch comprises the following steps:
(1) taking starch and hydroxyethyl cellulose, wherein the mass ratio of the starch to the hydroxyethyl cellulose is 6:1, adding water, wherein the addition amount of the water is 9 times of the mass of the starch, stirring to obtain an emulsion, and adjusting the pH of the emulsion to 8.0 by using a sodium hydroxide aqueous solution with the mass concentration of 2% to obtain a mixed solution;
(2) taking octenyl succinic anhydride, wherein the mass of the octenyl succinic anhydride is 2% of that of the starch in the step (1), and adding absolute ethyl alcohol, wherein the addition amount of the absolute ethyl alcohol is 5 times of that of the octenyl succinic anhydride, so as to obtain an alcohol solution;
(3) adding the alcohol solution obtained in the step (2) into the mixed solution obtained in the step (1), stirring and reacting for 6 hours at 40 ℃, adjusting the pH of the system to 6.5 by using a hydrochloric acid solution with the concentration of 1mol/L after the reaction is finished, and performing suction filtration, drying and crushing to obtain an intermediate product;
(4) adding water into the intermediate product obtained in the step (3), wherein the addition amount of the water is 2 times of the mass of the intermediate product, uniformly stirring, adding anhydrous sodium sulfate, the addition amount of the anhydrous sodium sulfate is 1/5 of the mass of the intermediate product, uniformly stirring, adjusting the pH of the system to 11.5 by using a sodium hydroxide solution with the concentration of 1mol/L, stirring for 30min at room temperature, adding propylene oxide, the addition amount of the propylene oxide is 1/5 of the mass of the intermediate product, stirring for 30min at room temperature, reacting for 10h at 40 ℃, adjusting the pH of the system to 6.5 by using a hydrochloric acid solution with the concentration of 1mol/L after the reaction is finished, and performing suction filtration, drying and crushing to obtain the intermediate product.
The preparation method of the capsule for promoting blood circulation and relieving pain comprises the following steps:
s1, weighing borneol respectively, and manually and uniformly mixing the borneol and the angelica sinensis sterilization powder with the same mass as the borneol to obtain mixed powder I; weighing angelica sterilizing powder 2 times the mass of borneol and the mixed powder I, adding the mixture into a two-dimensional motion mixer, starting up the two-dimensional motion mixer, mixing for 3 minutes, stopping the two-dimensional motion mixer, opening a total mixing tank, adding the angelica sterilizing powder 4 times the mass of the borneol, starting up the two-dimensional motion mixer, mixing for 3 minutes, and stopping the two-dimensional motion mixer; opening the total mixing tank, adding the rest of the angelica sinensis sterilization powder, starting the machine for mixing for 5 minutes, and discharging to obtain a material; pulverizing the above materials with GFSJ-16 high efficiency pulverizer, sieving with 14 mesh sieve to obtain GUIBINGBING powder;
s2, respectively weighing vinegar frankincense and calcined native copper sterilizing powder, smashing the weighed vinegar frankincense into small blocks of 2cm by using a stainless steel hammer to obtain vinegar frankincense blocks, uniformly mixing the vinegar frankincense blocks and the calcined native copper sterilizing powder according to the ratio of 2:3, crushing by using a GFSJ-16 efficient crusher, sieving by using a 14-mesh inspection sieve after crushing, and sieving to obtain vinegar frankincense and calcined native copper mixed powder;
s3, sequentially putting the angelica and borneol mixed powder obtained in the step S1, the ground beeltle sterilization powder, the vinegar frankincense and calcined pyrite mixed powder obtained in the step S2, the pseudo-ginseng sterilization powder and pharmaceutically acceptable auxiliary materials into a EYH-1000 type two-dimensional motion mixer for total mixing, wherein the mixing time is 30 minutes, and the rotating speed frequency of the mixer is 35Hz, so that the blood circulation-activating and pain-relieving mixed powder is obtained;
s4, filling the blood circulation-promoting and pain-relieving mixed powder obtained in the step S3 into a No. 1 all-red empty capsule, wherein the marked filling amount is 0.25 g/capsule, and the Chinese medicine composition is obtained.
Example 5A blood circulation promoting and pain relieving Capsule
The blood circulation promoting and pain relieving capsule consists of blood circulation promoting and pain relieving mixed powder and a capsule shell, wherein the blood circulation promoting and pain relieving mixed powder consists of the following components in parts by weight:
170 parts of angelica sinensis sterilization powder, 30 parts of pseudo-ginseng sterilization powder, 30 parts of vinegar frankincense, 50 parts of calcined native copper sterilization powder, 80 parts of ground beeltle sterilization powder, 8 parts of borneol and 8 parts of pharmaceutically acceptable auxiliary materials; the pharmaceutically acceptable auxiliary materials comprise modified starch, magnesium stearate, polyvinylpyrrolidone and pectin according to a mass ratio of 18:10:6: 3.
The modified starch was prepared in a manner similar to that described in example 4.
The preparation method of the capsule for promoting blood circulation and relieving pain comprises the following steps:
s1, weighing borneol respectively, and manually and uniformly mixing the borneol and the angelica sinensis sterilization powder with the same mass as the borneol to obtain mixed powder I; weighing angelica sterilizing powder 2 times the mass of borneol and the mixed powder I, adding the mixture into a two-dimensional motion mixer, starting up the two-dimensional motion mixer, mixing for 3 minutes, stopping the two-dimensional motion mixer, opening a total mixing tank, adding the angelica sterilizing powder 4 times the mass of the borneol, starting up the two-dimensional motion mixer, mixing for 3 minutes, and stopping the two-dimensional motion mixer; opening the total mixing tank, adding the rest of the angelica sinensis sterilization powder, starting the machine for mixing for 5 minutes, and discharging to obtain a material; pulverizing the above materials with GFSJ-16 high efficiency pulverizer, sieving with 14 mesh sieve to obtain GUIBINGBING powder;
s2, respectively weighing vinegar frankincense and calcined native copper sterilizing powder, smashing the weighed vinegar frankincense into small blocks of 2cm by using a stainless steel hammer to obtain vinegar frankincense blocks, uniformly mixing the vinegar frankincense blocks and the calcined native copper sterilizing powder according to the ratio of 2:3, crushing by using a GFSJ-16 efficient crusher, sieving by using a 14-mesh inspection sieve after crushing, and sieving to obtain vinegar frankincense and calcined native copper mixed powder;
s3, sequentially putting the angelica and borneol mixed powder obtained in the step S1, the ground beeltle sterilization powder, the vinegar frankincense and calcined pyrite mixed powder obtained in the step S2, the pseudo-ginseng sterilization powder and pharmaceutically acceptable auxiliary materials into a EYH-1000 type two-dimensional motion mixer for total mixing, wherein the mixing time is 30 minutes, and the rotating speed frequency of the mixer is 40Hz, so that the blood circulation-activating and pain-relieving mixed powder is obtained;
s4, filling the blood circulation-promoting and pain-relieving mixed powder obtained in the step S3 into a No. 1 all-red empty capsule, wherein the marked filling amount is 0.25 g/capsule, and the Chinese medicine composition is obtained.
Example 6A blood circulation promoting and pain relieving Capsule
The blood circulation promoting and pain relieving capsule consists of blood circulation promoting and pain relieving mixed powder and a capsule shell, wherein the blood circulation promoting and pain relieving mixed powder consists of the following components in parts by weight:
190 parts of angelica sinensis sterilization powder, 40 parts of pseudo-ginseng sterilization powder, 40 parts of vinegar frankincense, 60 parts of calcined native copper sterilization powder, 100 parts of ground beeltle sterilization powder, 10 parts of borneol and 16 parts of pharmaceutically acceptable auxiliary materials; the pharmaceutically acceptable auxiliary materials comprise modified starch, magnesium stearate, polyvinylpyrrolidone and pectin according to a mass ratio of 22:7:4: 1.
The preparation method of the modified starch, blood circulation promoting and pain relieving capsule is similar to that of example 4.
Comparative example 1A blood circulation promoting and pain relieving Capsule
The blood circulation promoting and pain relieving capsule consists of blood circulation promoting and pain relieving mixed powder and a capsule shell, wherein the blood circulation promoting and pain relieving mixed powder consists of the following components in parts by weight:
179.82 parts of angelica sinensis sterilization powder, 35.64 parts of pseudo-ginseng sterilization powder, 35.64 parts of vinegar frankincense, 54.27 parts of calcined native copper sterilization powder, 89.91 parts of ground beetle sterilization powder, 8.91 parts of borneol and 12 parts of pharmaceutically acceptable auxiliary materials; the pharmaceutically acceptable auxiliary materials comprise modified starch, magnesium stearate, polyvinylpyrrolidone and pectin according to the mass ratio of 1:1:1: 1.
The preparation method of the modified starch, blood circulation promoting and pain relieving capsule is similar to that of example 4.
The difference from the example 4 is that the pharmaceutically acceptable auxiliary materials consist of modified starch, magnesium stearate, polyvinylpyrrolidone and pectin according to the mass ratio of 1:1:1: 1.
Comparative example 2A blood circulation promoting and pain relieving Capsule
The blood circulation promoting and pain relieving capsule consists of blood circulation promoting and pain relieving mixed powder and a capsule shell, wherein the blood circulation promoting and pain relieving mixed powder consists of the following components in parts by weight:
179.82 parts of angelica sinensis sterilization powder, 35.64 parts of pseudo-ginseng sterilization powder, 35.64 parts of vinegar frankincense, 54.27 parts of calcined native copper sterilization powder, 89.91 parts of ground beetle sterilization powder, 8.91 parts of borneol and 12 parts of pharmaceutically acceptable auxiliary materials; the pharmaceutically acceptable auxiliary materials comprise starch, magnesium stearate, polyvinylpyrrolidone and pectin according to the mass ratio of 20:9:5: 2.
The preparation method of the blood circulation promoting and pain relieving capsule is similar to that of example 4.
The difference from example 4 is that the pharmaceutically acceptable excipients consist of starch, magnesium stearate, polyvinylpyrrolidone and pectin in a mass ratio of 20:9:5:2, i.e. no modification of the starch is performed.
Comparative example 3A blood circulation promoting and pain relieving Capsule
The blood circulation promoting and pain relieving capsule consists of blood circulation promoting and pain relieving mixed powder and a capsule shell, wherein the blood circulation promoting and pain relieving mixed powder consists of the following components in parts by weight:
179.82 parts of angelica sinensis sterilization powder, 35.64 parts of pseudo-ginseng sterilization powder, 35.64 parts of vinegar frankincense, 54.27 parts of calcined native copper sterilization powder, 89.91 parts of ground beetle sterilization powder, 8.91 parts of borneol and 12 parts of pharmaceutically acceptable auxiliary materials; the pharmaceutically acceptable auxiliary materials comprise modified starch, magnesium stearate and polyvinylpyrrolidone in a mass ratio of 20:9: 5.
The preparation method of the modified starch, blood circulation promoting and pain relieving capsule is similar to that of example 4.
The difference from example 4 is that the pharmaceutically acceptable auxiliary materials consist of modified starch, magnesium stearate and polyvinylpyrrolidone in a mass ratio of 20:9:5, i.e. no pectin is added.
Comparative example 4A blood circulation promoting and pain relieving Capsule
The blood circulation promoting and pain relieving capsule consists of blood circulation promoting and pain relieving mixed powder and a capsule shell, wherein the blood circulation promoting and pain relieving mixed powder consists of the following components in parts by weight:
179.82 parts of angelica sinensis sterilization powder, 35.64 parts of pseudo-ginseng sterilization powder, 35.64 parts of vinegar frankincense, 54.27 parts of calcined native copper sterilization powder, 89.91 parts of ground beetle sterilization powder, 8.91 parts of borneol and 12 parts of pharmaceutically acceptable auxiliary materials; the pharmaceutically acceptable auxiliary materials comprise modified starch, magnesium stearate, polyvinylpyrrolidone and pectin according to a mass ratio of 20:9:5: 2.
The preparation method of the modified starch, blood circulation promoting and pain relieving capsule is similar to that of example 4.
The difference from example 4 is that hydroxyethyl cellulose is not added in step (1) of the process for preparing the modified starch.
Comparative example 5A blood circulation promoting and pain relieving Capsule
The blood circulation promoting and pain relieving capsule consists of blood circulation promoting and pain relieving mixed powder and a capsule shell, wherein the blood circulation promoting and pain relieving mixed powder consists of the following components in parts by weight:
179.82 parts of angelica sinensis sterilization powder, 35.64 parts of pseudo-ginseng sterilization powder, 35.64 parts of vinegar frankincense, 54.27 parts of calcined native copper sterilization powder, 89.91 parts of ground beetle sterilization powder, 8.91 parts of borneol and 12 parts of pharmaceutically acceptable auxiliary materials; the pharmaceutically acceptable auxiliary materials comprise modified starch, magnesium stearate, polyvinylpyrrolidone and pectin according to a mass ratio of 20:9:5: 2.
The preparation method of the modified starch, blood circulation promoting and pain relieving capsule is similar to that of example 4.
The difference from example 4 is that the mass ratio of starch to hydroxyethyl cellulose in step (1) of the preparation method of the modified starch is 1: 1.
Comparative example 6A blood circulation promoting and pain relieving Capsule
The blood circulation promoting and pain relieving capsule consists of blood circulation promoting and pain relieving mixed powder and a capsule shell, wherein the blood circulation promoting and pain relieving mixed powder consists of the following components in parts by weight:
179.82 parts of angelica sinensis sterilization powder, 35.64 parts of pseudo-ginseng sterilization powder, 35.64 parts of vinegar frankincense, 54.27 parts of calcined native copper sterilization powder, 89.91 parts of ground beetle sterilization powder, 8.91 parts of borneol and 12 parts of pharmaceutically acceptable auxiliary materials; the pharmaceutically acceptable auxiliary materials comprise modified starch, magnesium stearate, polyvinylpyrrolidone and pectin according to a mass ratio of 20:9:5: 2.
The preparation method of the modified starch comprises the following steps:
(1) taking starch and hydroxyethyl cellulose, wherein the mass ratio of the starch to the hydroxyethyl cellulose is 6:1, adding water, wherein the addition amount of the water is 9 times of the mass of the starch, stirring to obtain an emulsion, and adjusting the pH of the emulsion to 8.0 by using a sodium hydroxide aqueous solution with the mass concentration of 2% to obtain a mixed solution;
(2) taking octenyl succinic anhydride, wherein the mass of the octenyl succinic anhydride is 2% of that of the starch in the step (1), and adding absolute ethyl alcohol, wherein the addition amount of the absolute ethyl alcohol is 5 times of that of the octenyl succinic anhydride, so as to obtain an alcohol solution;
(3) and (3) adding the alcohol solution obtained in the step (2) into the mixed solution obtained in the step (1), stirring and reacting for 6 hours at 40 ℃, adjusting the pH of the system to 6.5 by using a hydrochloric acid solution with the concentration of 1mol/L after the reaction is finished, and performing suction filtration, drying and crushing to obtain the alcohol-containing water-soluble organic fertilizer.
The preparation method of the blood circulation promoting and pain relieving capsule is similar to that of example 4.
The difference from example 4 is that the process for the preparation of the modified starch does not comprise step (4).
Test example I, moisture absorption test
1. Test samples: the blood-activating and pain-relieving capsules prepared in example 4, example 5, example 6, comparative example 1, comparative example 2 and comparative examples 4-6.
2. The test method comprises the following steps:
(1) placing the supersaturated sodium chloride solution in a glass dryer at room temperature to balance the internal humidity thereof to form an environment with different relative humidity, wherein the relative humidity of the dryer is 75%;
(2) drying the mixed powder for activating blood and relieving pain obtained in the steps S3 of the examples 4-6, the comparative example 1, the comparative example 2 and the comparative examples 4-6 to constant weight, placing 1.0g of the mixed powder for activating blood and relieving pain dried to constant weight into a flat weighing bottle with constant weight, precisely weighing, opening a weighing bottle cap, placing into a drier with the relative humidity of 75%, weighing after 48 hours, and calculating the moisture absorption rate, wherein the calculation formula is as follows:
moisture absorption rate = (mass after moisture absorption-mass before moisture absorption)/mass before moisture absorption × 100%.
3. And (3) test results: the results of the hygroscopicity test are shown in Table 1.
Table 1: results of moisture absorption test
As can be seen from Table 1, the mixed powder for promoting blood circulation and relieving pain prepared by the invention has low moisture absorption rate, wherein the moisture absorption rate of example 4 is the lowest and is the best example of the invention; compared with comparative example 1, comparative example 2 and comparative examples 4 to 6, the blood circulation promoting and pain relieving mixed powder has lower moisture absorption rate. Therefore, the auxiliary materials consisting of the modified starch, the magnesium stearate, the polyvinylpyrrolidone and the pectin effectively reduce the moisture absorption capacity of the blood-activating and pain-relieving mixed powder. Test example two, flowability and filling amount difference test
1.1, fluidity test:
the angle of repose was determined by the fixed cone method using the blood-activating pain-relieving mixed powder obtained in step S3 of examples 4 to 6, comparative example 1, comparative example 2, and comparative examples 4 to 6. The angle of repose is a method for testing the flowability of the powder, the smaller the angle of repose is, the smaller the friction force is, the better the flowability is, and the requirement of producing the flowability can be met when the angle of repose of the general powder particles is less than 40 degrees.
1.2 load differential test
The blood-activating and pain-relieving capsules prepared in examples 4-6, comparative example 1, comparative example 2 and comparative example 4-6 were tested for the difference in the amount according to the method for testing the difference in the amount in 10 capsules according to the third division of the pharmacopoeia of China 2015. 2. And (3) test results: the results of the measurement of the difference between the fluidity and the loading are shown in Table 2.
Table 2: measurement results of fluidity and filling amount difference
As can be seen from table 2, the difference in the filling amount of the blood-activating and pain-relieving capsules prepared by the present invention is in accordance with the regulations, and the fluidity of the blood-activating and pain-relieving mixed powder prepared by the present invention is better, wherein the best fluidity and the smallest difference in the filling amount are the best examples of the present invention in example 4. Compared with comparative example 1, comparative example 2 and comparative examples 4 to 6, the blood circulation promoting and pain relieving mixed powder has more excellent fluidity and smaller difference of filling amount.
Test example three, Long term stability test
1. Test materials: the blood-activating and pain-relieving capsules prepared in examples 4-6 and comparative examples 1-6.
2. The test method comprises the following steps:
placing the product in commercial package at 25 + -2 deg.C and relative humidity of 60 + -10% for 36 months, sampling for 0 month and 36 months, respectively, and inspecting the properties, identification, disintegration time, water content, and microorganism limit according to quality standard of the capsule.
3. And (3) test results: the stability test results are shown in table 3.
Table 3: long term stability test results
As can be seen from table 3, the blood-activating and pain-relieving capsules prepared in examples 4 to 6 meet the requirements of properties, identification, disintegration time limit, moisture and the like after being stored for 36 months at 25 ℃ and 60% relative humidity, which indicates that the blood-activating and pain-relieving capsules prepared by the invention have high stability and long shelf life; compared with comparative examples 1-6, the blood-circulation-promoting and pain-relieving capsules prepared in example 4 of the invention have higher stability, which shows that the blood-circulation-promoting and pain-relieving capsules of the invention are not easy to deteriorate and have stable properties when being placed for a long time.
Test example four analgesic test
1. Test subjects: 130 female Kunming mice are selected, and the weight is 25-30 g.
2. Test materials: the blood-activating and pain-relieving capsules prepared in example 4, example 5, example 6 and comparative examples 1 to 6; aspirin, available from Hongyong Biotech limited Hubei.
3. The test method comprises the following steps:
placing 130 mice on a hot plate pain measuring instrument, discarding the time of the foot licking for <5s or >30s, setting the cutoff time to be 60s to prevent the foot from being scalded, taking the latency period of the foot licking reaction of the mice as a pain threshold index, and screening the mice with the time of the foot licking for >5s and <30 s.
110 qualified mice are selected and randomly divided into 11 groups, each group comprises 10 mice, and the groups respectively comprise a blank control group, an aspirin group, an example 4 group, an example 5 group, an example 6 group and comparative examples 1-6 groups. The treatment groups are respectively administrated by intragastric administration with corresponding medicines, 1 mg/time, 1 time/day, and 5 days continuously, and the blank control group is administrated with normal saline with the same quality by intragastric administration. And measuring the time of the foot licking reaction at 60min and 120min after the last drug.
4. And (3) test results:
the test results are shown in table 4.
Table 4: mouse licking reaction latency time table
| Group of | Licking time(s) after 60min | Licking time(s) after 120min |
| Blank control group | 16.2 | 17.4 |
| Aspirin group | 27.9 | 28.5 |
| EXAMPLE 4 group | 31.7 | 34.8 |
| EXAMPLE 5 group | 28.4 | 30.3 |
| EXAMPLE 6 group | 29.6 | 32.1 |
| Comparative example 1 group | 24.8 | 25.6 |
| Comparative example 2 group | 20.1 | 20.8 |
| Comparative example 3 group | 22.7 | 23.6 |
| Comparative example 4 group | 22.2 | 23.1 |
| Comparative example 5 group | 23.4 | 23.9 |
| Comparative example 6 group | 21.6 | 22.5 |
As can be seen from table 4, compared with the blank control group, the blood-activating and pain-relieving capsule prepared by the invention can obviously prolong the foot licking time of mice, and has better pain-relieving effect than aspirin; compared with the groups of comparative examples 1-6, the capsule for promoting blood circulation and relieving pain provided by the invention has better analgesic effect.
Test example five anti-inflammatory and detumescence test
1. Test subjects: 110 female Kunming mice were selected, weighing 30 g.
2. Test materials: the blood-activating and pain-relieving capsules prepared in example 4, example 5, example 6 and comparative examples 1 to 6; aspirin, available from Hongyong Biotech limited Hubei.
3. The test method comprises the following steps:
the method comprises the following steps of randomly dividing 110 mice into 11 groups, namely a blank control group, an aspirin group, an example 4 group, an example 5 group, an example 6 group and a comparative example 1-6 group, wherein 10 mice in each group are uniformly coated with 50 mu L of dimethylbenzene on the right ear of each group, the left ear of each group is used as a control, after 2 hours of inflammation, each treatment group is respectively administered with corresponding medicines through gastric perfusion for 1 mg/time and 1 time/day for 5 consecutive days, and the blank control group is administered with physiological saline with the same quality through gastric perfusion.
And (3) removing the vertebra after administration for 12h, killing the patient, cutting two ears along the auricle, punching round ear pieces on the same parts of the left ear and the right ear by using an 8mm puncher, weighing, and calculating the ear weight difference, wherein the ear weight difference is equal to the weight of the round ear piece of the right ear and the weight of the round ear piece of the left ear.
4. And (3) test results:
the test results are shown in table 5.
Table 5: effect of blood circulation promoting and pain relieving capsules on swelling caused by mouse conchiolene
| Group of | Ear weight difference (mg) |
| Blank control group | 9.45 |
| Aspirin group | 4.27 |
| EXAMPLE 4 group | 4.14 |
| EXAMPLE 5 group | 4.72 |
| EXAMPLE 6 group | 4.49 |
| Comparative example 1 group | 5.86 |
| Comparative example 2 group | 7.82 |
| Comparative example 3 group | 6.76 |
| Comparative example 4 group | 6.48 |
| Comparative example 5 group | 6.14 |
| Comparative example 6 group | 6.58 |
As can be seen from table 5, the differences in ear weight of the mice in the groups of example 4, example 5 and example 6 were significantly reduced, the anti-inflammatory effect was significant, and the anti-inflammatory effect was close to that of aspirin, compared to the blank control group; the anti-inflammatory effects were more pronounced in the mice of the groups of examples 4-6 of the present invention compared to the groups of comparative examples 1-6.
Claims (4)
1. The blood circulation promoting and pain relieving capsule is characterized by comprising blood circulation promoting and pain relieving mixed powder and a capsule shell, wherein the blood circulation promoting and pain relieving mixed powder comprises the following components in parts by weight:
179.82 parts of angelica sinensis sterilization powder, 35.64 parts of pseudo-ginseng sterilization powder, 35.64 parts of vinegar frankincense, 54.27 parts of calcined native copper sterilization powder, 89.91 parts of ground beetle sterilization powder, 8.91 parts of borneol and 12 parts of pharmaceutically acceptable auxiliary materials;
the pharmaceutically acceptable auxiliary materials comprise modified starch, magnesium stearate, polyvinylpyrrolidone and pectin according to the mass ratio of 18-22:7-10:4-6: 1-3;
the preparation method of the modified starch comprises the following steps:
(1) taking starch and hydroxyethyl cellulose, wherein the mass ratio of the starch to the hydroxyethyl cellulose is 6:1, adding water, wherein the addition amount of the water is 9 times of the mass of the starch, stirring to obtain an emulsion, and adjusting the pH of the emulsion to 8.0 by using a sodium hydroxide aqueous solution with the mass concentration of 2% to obtain a mixed solution;
(2) taking octenyl succinic anhydride, wherein the mass of the octenyl succinic anhydride is 2% of that of the starch in the step (1), and adding absolute ethyl alcohol, wherein the addition amount of the absolute ethyl alcohol is 5 times of that of the octenyl succinic anhydride, so as to obtain an alcohol solution;
(3) adding the alcohol solution obtained in the step (2) into the mixed solution obtained in the step (1), stirring and reacting for 6 hours at 40 ℃, adjusting the pH of the system to 6.5 by using a hydrochloric acid solution with the concentration of 1mol/L after the reaction is finished, and performing suction filtration, drying and crushing to obtain an intermediate product;
(4) adding water into the intermediate product obtained in the step (3), wherein the addition amount of the water is 2 times of the mass of the intermediate product, uniformly stirring, adding anhydrous sodium sulfate, the addition amount of the anhydrous sodium sulfate is 1/5 of the mass of the intermediate product, uniformly stirring, adjusting the pH of the system to 11.5 by using a sodium hydroxide solution with the concentration of 1mol/L, stirring for 30min at room temperature, adding propylene oxide, the addition amount of the propylene oxide is 1/5 of the mass of the intermediate product, stirring for 30min at room temperature, reacting for 10h at 40 ℃, adjusting the pH of the system to 6.5 by using a hydrochloric acid solution with the concentration of 1mol/L after the reaction is finished, and performing suction filtration, drying and crushing to obtain the intermediate product.
2. The capsule according to claim 1, wherein the pharmaceutically acceptable excipients comprise modified starch, magnesium stearate, polyvinylpyrrolidone and pectin in a mass ratio of 20:9:5: 2.
3. The method for preparing a capsule for promoting blood circulation and relieving pain according to claim 1 or 2, comprising the steps of:
s1, weighing borneol respectively, and manually and uniformly mixing the borneol and the angelica sinensis sterilization powder with the same mass as the borneol to obtain mixed powder I; weighing angelica sterilizing powder 2 times the mass of borneol and the mixed powder I, adding the mixture into a two-dimensional motion mixer, starting up the two-dimensional motion mixer, mixing for 3 minutes, stopping the two-dimensional motion mixer, opening a total mixing tank, adding the angelica sterilizing powder 4 times the mass of the borneol, starting up the two-dimensional motion mixer, mixing for 3 minutes, and stopping the two-dimensional motion mixer; opening the total mixing tank, adding the rest of the angelica sinensis sterilization powder, starting the machine for mixing for 5 minutes, and discharging to obtain a material; pulverizing the above materials with GFSJ-16 high efficiency pulverizer, sieving with 14 mesh sieve to obtain GUIBINGBING powder;
s2, respectively weighing vinegar frankincense and calcined native copper sterilizing powder, smashing the weighed vinegar frankincense into small blocks of 2cm by using a stainless steel hammer to obtain vinegar frankincense blocks, uniformly mixing the vinegar frankincense blocks and the calcined native copper sterilizing powder according to the ratio of 2:3, crushing by using a GFSJ-16 efficient crusher, sieving by using a 14-mesh inspection sieve after crushing, and sieving to obtain vinegar frankincense and calcined native copper mixed powder;
s3, sequentially putting the angelica and borneol mixed powder obtained in the step S1, the ground beeltle sterilization powder, the vinegar frankincense and calcined pyrite mixed powder obtained in the step S2, the pseudo-ginseng sterilization powder and pharmaceutically acceptable auxiliary materials into a EYH-1000 type two-dimensional motion mixer for total mixing, wherein the mixing time is 30 minutes, and the rotating speed frequency of the mixer is 35-40 Hz, so that the blood circulation activating and pain relieving mixed powder is obtained;
s4, filling the mixed powder for promoting blood circulation and relieving pain obtained in the step S3 with a capsule shell, wherein the marked filling amount is 0.25 g/capsule, and the Chinese medicine preparation is obtained.
4. The method for preparing a capsule for promoting blood circulation to arrest pain according to claim 3, wherein the capsule shell in step S4 is a No. 1 red whole empty capsule.
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